Amicus Curiae Brief — Xiulu Ruan, Petitioner v. United States
Supreme Court briefDec 21, 2021
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Nos. 20-1410 & 21-5261
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In The
Supreme Court of the United States
---------------------------------♦--------------------------------DR. XIULU RUAN,
Petitioner,
v.
UNITED STATES OF AMERICA,
Respondent.
---------------------------------♦--------------------------------SHAKEEL KAHN,
Petitioner,
v.
UNITED STATES OF AMERICA,
Respondent.
---------------------------------♦--------------------------------On Writs Of Certiorari To The
United States Courts Of Appeals
For The Tenth And Eleventh Circuits
---------------------------------♦--------------------------------BRIEF OF AMICUS CURIAE
COMPASSION & CHOICES
IN SUPPORT OF PETITIONERS
---------------------------------♦--------------------------------TONKON TORP LLP
ROBERT A. KOCH
Counsel of Record
STEVEN M. WILKER
888 SW Fifth Avenue,
Suite 1600
Portland, OR 97204
Telephone: (503) 221-1440
robert.koch@tonkon.com
COMPASSION & CHOICES
KEVIN DÍAZ
101 SW Madison Street,
Unit 8009
Portland, OR 97207
Telephone: (503) 943-6535
Counsel for Amicus Curiae Compassion & Choices
================================================================================================================
COCKLE LEGAL BRIEFS (800) 225-6964
WWW.COCKLELEGALBRIEFS.COM
i
TABLE OF CONTENTS
Page
TABLE OF CONTENTS ......................................
i
TABLE OF AUTHORITIES .................................
ii
INTEREST OF AMICUS CURIAE ......................
1
SUMMARY OF ARGUMENT ..............................
2
ARGUMENT ........................................................
3
I.
II.
THE LAW PROVIDES A GOOD FAITH
DEFENSE FOR MEDICAL PRACTITIONERS ............................................................
3
EXCLUDING A GOOD FAITH DEFENSE
FOR MEDICAL PRACTITIONERS HARMS
END-OF-LIFE PATIENT CARE ...............
5
CONCLUSION..................................................... 11
ii
TABLE OF AUTHORITIES
Page
CASES
Gonzales v. Oregon, 546 U.S. 243 (2006) ......................4
United States v. Feingold, 454 F.3d 1001 (9th Cir.
2006) ..........................................................................5
United States v. Khan, 989 F.3d 806 (10th Cir.
2021) ................................................................ 2, 7, 11
United States v. Kohli, 847 F.3d 483 (7th Cir.
2017) ..........................................................................5
United States v. Moore, 423 U.S. 122 (1975) ...... 3, 4, 10
United States v. Ruan, 966 F.3d 1101 (11th Cir.
2020) ................................................................ 2, 7, 11
United States v. Sabean, 885 F.3d 27 (1st Cir.
2018) ..........................................................................4
United States v. Volkman, 797 F.3d 377 (6th Cir.
2015) ..........................................................................5
United States v. Wexler, 522 F.3d 194 (2d Cir.
2008) ..........................................................................5
STATUTES
21 C.F.R. § 1306.04(a) ...................................................3
21 U.S.C. § 802(21) ........................................................3
21 U.S.C. § 841(a)(1) .....................................................3
iii
TABLE OF AUTHORITIES—Continued
Page
OTHER AUTHORITIES
Am. Med. Ass’n, Health & Ethics Policy H-149.966:
Decisions Near End of Life, available at https://
policysearch.ama-assn.org/policyfinder/detail/
H-140.966%20Decisions%20Near%20the%20
End%20of%20Life?uri=%2FAMADoc%2FHOD.
xml-0-497.xml (last visited Dec. 16, 2021) ...............6
Andrea C. Enzinger et al., US Trends in Opioid
Access Among Patients with Poor Prognosis
Cancer Near the End-of-Life, 39 J. Clin. Oncology 2948 (2021) ................................................. 6, 9
Diane E. Hoffmann, Treating Pain v. Reducing
Drug Diversion and Abuse: Recalibrating the
Balance in Our Drug Control Laws and Policies, 1 St. Louis U. J. Health L. & Pol’y 231
(2008) ....................................................... 5, 6, 7, 8, 10
Donald M. Goldenbaum et al., Physicians
Charged with Opioid Analgesic-Prescribing
Offenses, 9 Pain Med. 737 (2008), available at
https://academic.oup.com/painmedicine/article/
9/6/737/1909323 (last visited Dec. 16, 2021) ........ 7, 8
Ian Ayres & Amen Jalal, The Impact of Prescription Drug Monitoring Programs on U.S.
Opioid Prescriptions, 46 J. L. Med. & Ethics
387 (2018) ..................................................................6
iv
TABLE OF AUTHORITIES—Continued
Page
Joint Statement from 21 Health Orgs. & the
Drug Enf ’t Admin., Promoting Pain Relief
and Preventing Abuse of Pain Medications: A
Critical Balancing Act (2002), available at
https://www.deadiversion.usdoj.gov/pubs/
advisories/painrelief.pdf (last visited Dec. 16,
2021) .............................................................. 5, 6, 8, 9
Karen O. Anderson et al., Racial and Ethnic
Disparities in Pain: Causes and Consequences
of Unequal Care, 10 J. Pain 1187 (2009),
available at https://www.sciencedirect.com/
science/article/abs/pii/S1526590009007755 (last
visited Dec. 16, 2021) ................................................8
Kelly K. Dineen & James M. DuBois, Between a
Rock and a Hard Place: Can Physicians Prescribe Opioids to Treat Pain Adequately While
Avoiding Legal Sanction?, 42 Am. J. L. & Med.
7 (2016) .............................................................. 7, 8, 9
Kelly K. Dineen, Definitions Matter: A Taxonomy
of Inappropriate Prescribing to Shape Effective Opioid Policy and Reduce Patient Harm,
67 U. Kan. L. Rev. 961 (2019) ........................ 6, 7, 8, 9
Kelly M. Hoffman et al., Racial Bias in Pain
Assessment and Treatment Recommendation,
and False Beliefs About Biological Differences
Between Blacks and Whites, Proc. Nat’l Academy Sci. (Mar. 1, 2016), available at https://
www.pnas.org/content/113/16/4296 (last visited
Dec. 16, 2021) ............................................................8
v
TABLE OF AUTHORITIES—Continued
Page
Lindy Willmott et al., Providing Palliative Care
at the End of Life: Should Health Professionals Fear Regulation?, 26 J. L. & Med. 214
(2018), available at https://papers.ssrn.com/sol3/
papers.cfm?abstract_id=3274384 (last visited
Dec. 16, 2021) ............................................................9
Michael C. Barnes et al., Demanding Better: A
Case for Increased Funding and Involvement
of State Medical Boards in Response to
America’s Drug Abuse Crisis, 106 J. Med. Reg.
6 (2020), available at https://meridian.allen
press.com/jmr/article/106/3/6/447314/DemandingBetter-A-Case-for-Increased-Funding-and (last
visited Dec. 16, 2021) ...................................... 8, 9, 10
Nat’l Cancer Inst., Are Cancer Patients Getting
the Opioids They Need to Control Pain? (Sept.
16, 2020), available at https://www.cancer.
gov/news-events/cancer-currents-blog/2020/
opioids-cancer-pain-oncologists-decreasingprescriptions (last visited Dec. 16, 2021) .................9
Nat’l Cancer Inst., Opioid Use Drops Among
Cancer Patients at End of Life (Aug. 20, 2021),
available at https://www.cancer.gov/news-events/
cancer-currents-blog/2021/opioids-cancer-painend-of-life (last visited Dec. 16, 2021) .................. 6, 9
vi
TABLE OF AUTHORITIES—Continued
Page
Salimah H. Meghani et al., Time to Take Stock:
A Meta-Analysis and Systematic Review of
Analgesic Treatment Disparities for Pain in
the United States, 13 Pain Med. 150 (2012),
available at https://academic.oup.com/pain
medicine/article/13/2/150/1935962 (last visited
Dec. 16, 2021) ............................................................8
Sebastiano Mercadante et al., Controlled Sedation for Refractory Symptoms in Dying
Patients, 37 J. Pain & Symptom Mgmt. 771
(May 2009), available at https://www.science
direct.com/science/article/pii/S0885392408005
629 (last visited Dec. 16, 2021) .................................6
Vikram Jairam et al., Temporal Trends in Opioid
Prescribing Patterns Among Oncologists in the
Medicare Population, 113 J. Nat’l Cancer Inst.
274 (2021), available at https://academic.oup.
com/jnci/article/113/3/274/5891667 (last visited
Dec. 16, 2021) ............................................................9
1
INTEREST OF AMICUS CURIAE1
Compassion & Choices is the nation’s oldest,
largest, and most active 501(c)(3) nonprofit organization committed to improving care and expanding
choice at the end of life. Compassion & Choices advocates for high quality end-of-life medical care and
educates the public about available end-of-life options.
The organization’s stated vision is of a “society that
affirms life and accepts the inevitability of death,
embraces expanded options for compassionate dying,
and empowers everyone to choose end-of-life care that
reflects their values, priorities, and beliefs.”
To support this vision, Compassion & Choices
works to empower patients’ voices and agency in endof-life care, regardless of gender identity, age, sexuality,
race, ethnicity, religion, national origin, wealth, marital status, or disability. Compassion & Choices thus
files this amicus brief in support of petitioners to
highlight for the Court why the exclusion of a good
faith defense for practitioners under Section 841 of the
Controlled Substances Act not only contravenes the
law, but unduly chills the practice of medicine for
dying patients, particularly for pain and symptom
management for patients nearing the end of life.
---------------------------------♦--------------------------------1
Written consent to the filing of this brief has been granted
by all parties. No counsel for a party authored this brief, in whole
or in part, and no person other than amicus curiae and its counsel made any monetary contribution to fund the preparation or
submission of this brief.
2
SUMMARY OF ARGUMENT
The Tenth and Eleventh Circuits interpreted Section 841 of the Controlled Substances Act to exclude a
good faith defense for practitioner doctors charged
under the Act for their prescribing practices. United
States v. Khan, 989 F.3d 806, 825–26 (10th Cir. 2021);
United States v. Ruan, 966 F.3d 1101, 1166–67 (11th
Cir. 2020). This Court should reverse. Both the text of
the Act and this Court’s case law require a knowing or
intentional violation to impose criminal liability, in
particular, a knowing or intentional breach of medical
standards on prescribing controlled substances. The
denial of a good faith defense contravenes that required mens rea.
In addition, the erosion and ultimate elimination
of a good faith defense for medical practitioners under
the Act has harmed, and will continue to harm, patient
care. Specifically, by seeking to criminalize negligent
prescribing practices, law enforcement has chilled
the willingness of medical practitioners to prescribe
opioids to relieve pain and other symptoms that often
escalate sharply for those at the end of life. This
vulnerable population and their families have been
robbed of dignity and autonomy at one of the most
critical, and private, times in their lives—an outcome
that Congress never intended.
---------------------------------♦---------------------------------
3
ARGUMENT
I.
THE LAW PROVIDES A GOOD FAITH DEFENSE FOR MEDICAL PRACTITIONERS
The plain text of the Controlled Substances Act
provides a good faith defense for the prescribing
practices of medical practitioners. The Act makes it
“unlawful for any person [to] knowingly or intentionally . . . distribute, or dispense, a controlled substance”
in an unauthorized way. 21 U.S.C. § 841(a)(1). But the
Act also authorizes licensed and registered medical
practitioners to issue prescriptions for a legitimate
medical purpose in the usual course of their professional practice. See 21 U.S.C. § 802(21) (allowing
such practitioners “to distribute, dispense, [and]
conduct research with . . . a controlled substance in the
course of professional practice”); 21 C.F.R. § 1306.04(a)
(allowing prescriptions “issued for a legitimate medical
purpose by an individual practitioner acting in the
usual course of his professional practice”). By rendering obsolete whether a practitioner knew or intended
to prescribe a controlled substance in a way that was
unauthorized, the Tenth and Eleventh Circuits read
the terms “knowingly or intentionally” out of the
statute.
Similarly, this Court’s case law recognizes that
licensed and registered practitioners run afoul of the
Act only when they act as a drug “pusher” rather than
as a good-faith medical professional. United States v.
Moore, 423 U.S. 122, 143 (1975). In enacting the
Controlled Substances Act, “Congress was concerned
4
with the nature of the drug transaction, rather than
with the status of the defendant.” Id. at 134. At the
same time, “Congress understandably was concerned
that the drug laws not impede legitimate research and
that physicians be allowed reasonable discretion in
treating patients and testing new theories.” Id. at 143.
As a result, practitioners violate the Act if their
“conduct exceed[s] the bounds of professional practice”
despite “an honest effort to prescribe . . . in compliance
with an accepted standard of medical practice.” Id. at
142 & n.20 (internal quotation marks omitted). As
explained by this Court, under the Act, “Congress
regulates medical practice insofar as it bars doctors
from using their prescription-writing powers as a
means to engage in illicit drug dealing and trafficking
as conventionally understood. Beyond this, however,
the statute manifests no intent to regulate the practice
of medicine generally.” Gonzales v. Oregon, 546 U.S.
243, 270 (2006). This is due in part to federalism: in
the context of prescriptions by a medical professional,
“[t]he structure and operation of the [Controlled
Substances Act] presume and rely upon a functioning
medical profession regulated under the States’ police
powers.” Id.
In short, the Act criminalizes only those medical
practitioners who knowingly or intentionally act
without a legitimate purpose outside the usual course
of professional practice. As such, the law provides a
charged practitioner with a good faith defense due to
the mens rea required by the statute. See United States
v. Sabean, 885 F.3d 27, 44 (1st Cir. 2018) (“[E]ven a
5
negligent physician is inoculated against criminal
liability under Section 841(a) as long as he acts in good
faith.”); United States v. Kohli, 847 F.3d 483, 489–90
(7th Cir. 2017) (“[T]he evidence must show that the
physician not only intentionally distributed drugs, but
that he intentionally acted as a pusher rather than a
medical professional.” (cleaned up)); United States v.
Feingold, 454 F.3d 1001 (9th Cir. 2006) (“[A] practitioner who acts outside the usual course of professional
practice may be convicted under § 841(a) only if he
does so intentionally.”); see also United States v. Wexler,
522 F.3d 194, 205 (2d Cir. 2008) (allowing an “objective”
good faith defense); United States v. Volkman, 797 F.3d
377, 387 (6th Cir. 2015) (same).
II.
EXCLUDING A GOOD FAITH DEFENSE
FOR MEDICAL PRACTITIONERS HARMS
END-OF-LIFE PATIENT CARE
Opioids and other controlled substances sit at the
cross-section of medicine and law. For many suffering
from severe, escalating pain, opioids may be the only
treatment option currently offered by modern medicine that provides relief.2 This is particularly true for
cancer patients and other individuals as they near
2
Joint Statement from 21 Health Orgs. & the Drug Enf ’t
Admin., Promoting Pain Relief and Preventing Abuse of Pain
Medications: A Critical Balancing Act (2002), available at https://
www.deadiversion.usdoj.gov/pubs/advisories/painrelief.pdf (last
visited Dec. 16, 2021); Diane E. Hoffmann, Treating Pain v.
Reducing Drug Diversion and Abuse: Recalibrating the Balance
in Our Drug Control Laws and Policies, 1 St. Louis U. J. Health
L. & Pol’y 231, 266 (2008).
6
death.3 As declared by the American Medical Association, “[p]hysicians have an obligation to relieve pain
and suffering and to promote the dignity and autonomy of dying patients in their care.”4 And as reported
by the National Cancer Institute, opioids not only
improve quality of life in end-of-life care but, by “provid[ing] good supportive care, including pain management, people will actually live longer.”5
At the same time, over the past few decades,
opioid abuse became one of the worst drug overdose epidemics in the country’s history.6 In turn, law
3
Joint Statement, supra note 2; Hoffmann, supra note 2, at
266–67; Kelly K. Dineen, Definitions Matter: A Taxonomy of
Inappropriate Prescribing to Shape Effective Opioid Policy and
Reduce Patient Harm, 67 U. Kan. L. Rev. 961, 970 (2019); Nat’l
Cancer Inst., Opioid Use Drops Among Cancer Patients at End of
Life (Aug. 20, 2021), available at https://www.cancer.gov/newsevents/cancer-currents-blog/2021/opioids-cancer-pain-end-of-life
(last visited Dec. 16, 2021); Andrea C. Enzinger et al., US Trends
in Opioid Access Among Patients with Poor Prognosis Cancer
Near the End-of-Life, 39 J. Clin. Oncology 2948, 2955 (2021);
Sebastiano Mercadante et al., Controlled Sedation for Refractory
Symptoms in Dying Patients, 37 J. Pain & Symptom Mgmt. 771,
773, 777 (May 2009), available at https://www.sciencedirect.
com/science/article/pii/S0885392408005629 (last visited Dec. 16,
2021).
4
Am. Med. Ass’n, Health & Ethics Policy H-149.966: Decisions
Near End of Life, available at https://policysearch.ama-assn.
org/policyfinder/detail/H-140.966%20Decisions%20Near%20the%20
End%20of%20Life?uri=%2FAMADoc%2FHOD.xml-0-497.xml (last
visited Dec. 16, 2021).
5
Nat’l Cancer Inst., supra note 3.
6
Ian Ayres & Amen Jalal, The Impact of Prescription Drug
Monitoring Programs on U.S. Opioid Prescriptions, 46 J. L. Med.
& Ethics 387, 387 (2018).
7
enforcement began targeting opioid prescriptions
with the level of scrutiny previously applied to street
drugs like cocaine and heroin.7 As noted above in Part
I, part of that enforcement effort has included charging
medical practitioners for criminal violations of the
Controlled Substances Act due to prescribing practices
that, in the view of prosecutors, violated medical
practice standards, without due regard to the actual
state of mind of the practitioner. See, e.g., Khan, 989
F.3d at 825–26; Ruan, 966 F.3d at 1166–67.
These enhanced law enforcement efforts and
prosecutions have had a chilling effect on the prescribing of opioids by medical practitioners, including
those treating patients in good faith. Doctors are
trained to have a “truth bias”: to trust and empathize
with their patients.8 And no set definition exists for
what it means to overprescribe opioids, either medically or legally.9 Indeed, no consensus medical opinion
exists even on an upper limit for opioid prescriptions,
in volume or dosage, as opioids do not damage internal
organs like other pain relievers.10 Practitioners who
7
Hoffmann, supra note 2, at 234.
Hoffmann, supra note 2, at 257, 285, 303; Kelly K. Dineen
& James M. DuBois, Between a Rock and a Hard Place: Can
Physicians Prescribe Opioids to Treat Pain Adequately While
Avoiding Legal Sanction?, 42 Am. J. L. & Med. 7, 16–18 (2016).
9
Dineen, supra note 3, at 966–68, 986–87, 990; Donald M.
Goldenbaum et al., Physicians Charged with Opioid AnalgesicPrescribing Offenses, 9 Pain Med. 737, 744 (2008), available at
https://academic.oup.com/painmedicine/article/9/6/737/1909323 (last
visited Dec. 16, 2021).
10
Hoffmann, supra note 2, at 270, 287.
8
8
“overprescribe” opioids in the eyes of law enforcement
may do so for reasons that range “from careful (e.g., a
careful prescriber being fooled by a person feigning
pain to divert drugs to the market) to criminal (a
provider knowingly abandoning their provider role for
self-gain).”11 But in a world in which their good faith
may or may not matter, many medical practitioners
simply choose to limit or avoid prescribing opioids
altogether, regardless of patient need.12 These impacts hit particularly hard in racially diverse and
underserved communities, which already experience
disparities in pain treatment and care.13
11
Dineen, supra note 3, at 985.
Joint Statement, supra note 2; Hoffmann, supra note 2, at
235, 293, 296, 309; Dineen & DuBois, supra note 8, at 12, 17–18,
21–22, 35–40; Goldenbaum et al., supra note 9, at 745; Michael C.
Barnes et al., Demanding Better: A Case for Increased Funding
and Involvement of State Medical Boards in Response to America’s
Drug Abuse Crisis, 106 J. Med. Reg. 6, 6–8, 10, 17 (2020),
available at https://meridian.allenpress.com/jmr/article/106/3/6/
447314/Demanding-Better-A-Case-for-Increased-Funding-and (last
visited Dec. 16, 2021).
13
Karen O. Anderson et al., Racial and Ethnic Disparities in
Pain: Causes and Consequences of Unequal Care, 10 J. Pain 1187
(2009), available at https://www.sciencedirect.com/science/article/
abs/pii/S1526590009007755 (last visited Dec. 16, 2021); Kelly M.
Hoffman et al., Racial Bias in Pain Assessment and Treatment
Recommendation, and False Beliefs About Biological Differences
Between Blacks and Whites, Proc. Nat’l Academy Sci. (Mar. 1,
2016), available at https://www.pnas.org/content/113/16/4296
(last visited Dec. 16, 2021); Salimah H. Meghani et al., Time to
Take Stock: A Meta-Analysis and Systematic Review of Analgesic
Treatment Disparities for Pain in the United States, 13 Pain Med.
150 (2012), available at https://academic.oup.com/painmedicine/
article/13/2/150/1935962 (last visited Dec. 16, 2021).
12
9
This chilling effect also has extended to end-oflife medical care, including for those with terminal
cancer.14 For practitioners, “[a]n investigation alone
can be devastating[,] and a finding of liability can
trigger a cascade of consequences that make it impossible to practice medicine.”15 Therefore, rather than
focus on patient medical need, many practitioners fear
“being raided without notice, prosecuted and imprisoned, or losing their life savings to cover legal
costs.”16 This negative impact on patient care has
shown up most glaringly in emergency room visits: as
opioid prescriptions have dropped for those receiving
end-of-life care, emergency room visits for pain have
risen in kind.17
14
Joint Statement, supra note 2; Dineen, supra note 3, at
966; Nat’l Cancer Inst., supra note 3; Enzinger et al., supra note
3, at 2948, 2951, 2953, 2956; Nat’l Cancer Inst., Are Cancer
Patients Getting the Opioids They Need to Control Pain? (Sept. 16,
2020), available at https://www.cancer.gov/news-events/cancercurrents-blog/2020/opioids-cancer-pain-oncologists-decreasingprescriptions (last visited Dec. 16, 2021); Vikram Jairam et
al., Temporal Trends in Opioid Prescribing Patterns Among
Oncologists in the Medicare Population, 113 J. Nat’l Cancer Inst.
274, 274, 277, 280 (2021), available at https://academic.oup.
com/jnci/article/113/3/274/5891667 (last visited Dec. 16, 2021);
Lindy Willmott et al., Providing Palliative Care at the End of
Life: Should Health Professionals Fear Regulation?, 26 J. L. &
Med. 214, 215 nn.6–8 (2018) (collecting studies), available at
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3274384 (last
visited Dec. 16, 2021).
15
Dineen & DuBois, supra note 8, at 21–22.
16
Barnes et al., supra note 12, at 11.
17
Nat’l Cancer Inst., supra note 3; Enzinger et al., supra note
3, at 2948, 2951, 2953, 2956.
10
Patients receiving end-of-life care deserve better.
Medical practitioners prescribing opioids to such
patients in good faith are not drug pushers under the
Act. Moore, 423 U.S. at 143. Practitioners thus should
not have to suffer the specter of criminal liability
simply for treating such patients at such a vulnerable,
critical, and private time in their lives. Neither the text
of the statute nor this Court’s case law indicates that
Congress intended otherwise. Moreover, non-criminal
sanctions continue to protect the public, as the potential for professional discipline, loss of license, and civil
tort liability all serve as powerful deterrents against
reckless and negligent prescribing practices.18
---------------------------------♦---------------------------------
18
Hoffmann, supra note 2, at 307; Barnes et al., supra note
12, at 10–17.
11
CONCLUSION
Interpreting Section 841 of the CSA to include a
good faith defense for the prescribing practices of
practitioner doctors comports with the plain text and
context of the statute, this Court’s case law, and the
needs and rights of those facing end-of-life care.
Compassion & Choices thus urges this Court to reverse
the Tenth and Eleventh Circuit decisions to the contrary in Khan and Ruan, respectively.
Respectfully submitted,
TONKON TORP LLP
ROBERT A. KOCH
Counsel of Record
STEVEN M. WILKER
888 SW Fifth Avenue,
Suite 1600
Portland, OR 97204
Telephone: (503) 221-1440
robert.koch@tonkon.com
COMPASSION & CHOICES
KEVIN DÍAZ
101 SW Madison Street,
Unit 8009
Portland, OR 97207
Telephone: (503) 943-6535
Counsel for Amicus Curiae Compassion & Choices
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.